RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System

Status Completed

Clinical Trial Summary

To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.

Clinical Trial Description

To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.

This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00736086
Study type	Observational
Source	Abbott Vascular
Contact
Status	Completed
Phase	Phase 4
Start date	March 2006
Completion date	December 2006

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